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Morning Briefing

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Thursday, Jul 14 2022

Full Issue

FDA Authorizes Novavax Covid Vaccine, A Fourth Option For US

Instead of relying on mRNA technology, Novavax is the nation's first protein-based covid-19 vaccine. The two-dose shot should be available 鈥渋n the next few weeks," according to the Department of Health and Human Services, but first needs clearance from the CDC.

U.S. regulators Wednesday authorized the nation鈥檚 fourth coronavirus vaccine, a shot developed by Novavax, a Maryland biotechnology company that has been a straggler in the vaccine race. For a relatively small niche of people who want to be vaccinated, but can鈥檛 or won鈥檛 take existing vaccines, Wednesday鈥檚 decision by the Food and Drug Administration has been impatiently awaited. Some people are allergic to an ingredient in messenger RNA vaccines or simply prefer the more traditional technology at the core of Novavax鈥檚 shot, which is the United States鈥� first protein-based vaccine. (Johnson, 7/13)

The FDA鈥檚 signoff isn鈥檛 the last step: The decision will now to go the Centers for Disease Control and Prevention and its advisory committee to issue their own recommendation on how the shots should be used. The CDC鈥檚 Advisory Committee on Immunization Practices is scheduled to meet on July 19. (Lovelace Jr., 7/13)

In a trial of more than 26,000 adults in the U.S. and Mexico, two doses of the Novavax Covid vaccine were more than 90 percent effective at preventing symptomatic disease. For adults 65 and older, effectiveness was more than 78 percent. There were no serious side effects or safety concerns, including for the approximately 21,000 adults who were followed for more than two months after their second shot. (Foley and Lim, 7/13)

Novavax鈥檚 vaccine, given in doses spread three weeks apart, works differently from mRNA vaccines. It provokes an immune response with nanoparticles made up of proteins from the surface of the coronavirus that causes Covid-19. Similar protein-based vaccines have been widely used around the world for decades. (Robbins and Zimmer, 7/14)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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